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The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

• viewing the posterior segment of the eye, including two- and three-dimensional imaging
• cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
• fundus imaging
• fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

• age-related macular degeneration
• macular edema
• diabetic retinopathy
• retinal and choroidal vascular diseases
• glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:

• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser-scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.

The purpose of this premarket notification [510(k)] is to add the High Magnification Module (HMM) as an optional, exchangeable accessory objective lens to the SPECTRALIS HRA+OCT.

The HMM is offering an 8° field of view (FOV) and allows for cSLO imaging only. It offers a magnified view of parts of the retina with improved resolution. Compared to the standard objective with 30° FOV, it has an approximately 4 times increased digital resolution, with optical resolution approximately 25% improved compared to the standard objective. With the new HMM objective, the digital resolution for a FOV of 8° is 1536x1536 pixels for High Resolution imaging, and 768x768 pixels for High Speed imaging. The functionality for averaging images with the proprietary automatic real-time (ART) eye tracking is still maintained.

cSLO imaging with the HMM is only intended for qualitative use.

• No quantitative automatic measurements are performed on HMM images. -
• No classifications against reference data are performed on HMM images -

Besides the addition of the optional High Magnification Module, the SPECTRALIS device is unchanged.

The provided document describes a 510(k) premarket notification for a SPECTRALIS HRA+OCT device with a High Magnification Module (HMM). The notification focuses on demonstrating substantial equivalence to a previously cleared predicate device (K181594).

The acceptance criteria and study detailed pertain to the High Magnification Module (HMM), an optional accessory objective lens, and its impact on the existing SPECTRALIS HRA+OCT. The primary goal was to ensure the modified device (with HMM) is as safe and effective as the unmodified predicate device.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify a separate "test set" in the context of patient data or a clinical study for the HMM's performance. The evaluation was primarily based on non-clinical performance testing, simulations (ray tracing), and bench testing. There is no mention of patient data (retrospective or prospective) used specifically to validate the HMM.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth, in this context, was established through engineering simulations (ray tracing) and bench test measurements against predefined technical specifications and comparisons to the standard objective. There were no human experts establishing ground truth from clinical data for the HMM's performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring expert adjudication was described for the HMM.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device described (Spectralis HRA+OCT with HMM) is an ophthalmic diagnostic imaging device. The High Magnification Module (HMM) is an accessory objective lens for cSLO imaging only, intended for qualitative use, and specifically states:

• "No quantitative automatic measurements are performed on HMM images."
• "No classifications against reference data are performed on HMM images."
  This indicates that the HMM is not an AI-powered diagnostic tool, and therefore, an MRMC study related to AI assistance for human readers would not have been performed or relevant for this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The HMM is a hardware component (an objective lens) for an imaging device, not a standalone algorithm. Its function is to provide magnified cSLO images with improved resolution for qualitative viewing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the HMM's performance was based on:

• Theoretical values derived from ray tracing simulations for optical parameters.
• Measurements from bench testing to verify physical parameters like field of view, image geometry, lateral resolution, and image quality, against the standard objective.
• Compliance with FDA recognized consensus standards (ISO, AAMI, IEC standards).

8. The sample size for the training set:

Not applicable. The HMM is a hardware accessory; there is no "training set" in the context of machine learning or algorithms.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set mentioned, this question is not relevant to the provided information.

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